Priligy dapoxetine hydrochloride regulatory update

Furiex said the European Commission approved 30 and 60 mg Priligy dapoxetine to treat premature ejaculation (PE) in men ages 18-64. In 2009, an MAA for the product was approved under the EU's decentralized procedure, with Sweden as the reference state. However, EU member states were unable to reach an agreement due to concerns over the risk/benefit profile of the higher dose and the Swedish regulatory authorities referred the matter to EMA's CHMP for arbitration. In October, CHMP concluded that the benefits of 60 mg dose outweighed its risks (see BioCentury, Feb. 16, 2009). ...